Intravenous securement device with adhesively interconnected anchoring component and permeable adhesive strip

ABSTRACT

A catheter anchoring assembly includes a permeable adhesive strip, a platform for securing the catheter, and a flowable adhesive layer. The flowable adhesive layer adhesively secures the platform to the adhesive strip. The flowable adhesive is applied to one side of the strip with a skin-contacting adhesive on the opposite side of the strip. The flowable adhesive layer and strip are configured so that the flowable adhesive is spaced from the skin-contacting adhesive or, at the very least, is prevented from penetrating the skin-contacting adhesive. The flowable adhesive layer and strip also permit the assembly to be very flexible and, thus, comfortable for a patient to wear.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to the field of intravenousinfusion site devices. More specifically, the present invention concernsan intravenous catheter anchoring device with an adhesivelyinterconnected anchoring component and permeable adhesive strip for thesecurement of catheters on various infusion sites.

2. Discussion of Prior Art

Catheters for intravenous infusion into a patient are well known in theart. Such catheters are generally used in a variety of infusionapplications and on a variety of sites. For example, catheters arecommonly used as central venous catheters (“CVC”), midline catheters, orperipherally inserted central catheters (“PICC”). Secure positioning ofthe catheter is important because precise catheter location within thevenous system is normally critical.

One prior art technique for securing the catheter in place involves theuse of tape wrapped around the catheter and adhered to the patient. Asignificant problem associated with this technique is the increased riskof bloodstream infections, which typically require expensive andextended antibiotic therapy and can, in some instances, cause death. Inparticular, the securement tape is typically not sterile and securementgenerally can harbor bacteria. Furthermore, tape typically does notsufficiently prevent axial catheter movement in and out of thevenipuncture site (i.e., catheter pistoning). Therefore, any bacteria onthe catheter itself can be introduced into the bloodstream by pistoningof the catheter into the venipuncture site. Some prior art securementdevices are sutured onto the patient and these present an additionalpath for introducing bacteria into the bloodstream.

Consequently, securement devices have been developed for attaching thecatheter to the patient. The securement device usually includes a tapethat adheres to the patient's skin and a catheter retaining structureattached to the tape. The securement device typically includes a releaseliner covering the skin-contacting side of the tape, with the linerbeing removed prior to application of the device. The securement deviceis preferably designed for various applications and can be used tosecure catheters at various locations on the patient's body. Inparticular, the securement device must be able to adhere itself andconform to contoured surfaces including the patient's torso (in the caseof a CVC) as well as the patient's arm (in the case of a PICC).Moreover, patients with these catheters often want or need to have anormal range of body motion while the catheter is inserted and becomfortable while having the catheters secured. Therefore, people have aneed for a catheter anchoring device that provides reliable yetcomfortable catheter securement during patient movement.

Again, securement devices are often used with catheters to preventcatheter movement. However, these conventional securement devices areproblematic and suffer from various undesirable limitations.

Another problem is that the release liner used with these traditionalsecurement devices is generally difficult to remove. Specifically,techniques for attaching the tape to the rest of the device tend tointerfere with removal of the release liner.

Yet another problem is that the prior art securement devices arenormally uncomfortable to wear. For example, the prior art devicestypically use a tape substrate that is relatively stiff and does notconform to the patient during movement. In particular, the prior artdevices often use a foam-based substrate that does not readily bend. Theprior art substrates also are uncomfortable because they preventmoisture from evaporating from the skin surface, which often results inskin rashes or fungus growth. Foam-based substrates also make itdifficult to assess the condition of the patient's skin under thedevice. This type of material also has a tendency to degrade ordelaminate during use, which make dressing changes more difficult andproblematic.

Accordingly, there is a need for an improved intravenous catheteranchoring device that does not suffer from these problems andlimitations.

SUMMARY OF THE INVENTION

A first aspect of the present invention concerns an intravenous catheteranchoring device for securing a catheter to a patient. The devicebroadly includes a platform, a flexible and at least partly permeablestrip, a release liner, and an attachment layer. The platform isconfigured to couple to the catheter. The strip includes a plurality ofinterstices therein and presents first and second opposite surfaces. Thestrip is configured to be removably attached to the patient along thefirst surface. The strip includes a skin-contacting adhesive layeradhered to the first surface. The release liner is removably attached tothe first surface so that the first surface is at least partly coveredby the release liner before the strip is attached to the patient. Theattachment layer is located between and adheres the platform and stripalong a wetted portion of the second surface. The attachment layercomprises an adhesive material that is flowable prior to beingsolidified. The attachment layer extends from the wetted portion into atleast some of the interstices so that the adhesive material becomessolidified therein. The attachment layer is entirely spaced from therelease liner when solidified so that the attachment layer is restrictedfrom adhering the strip to the release liner.

A second aspect of the present invention concerns an intravenouscatheter anchoring device for securing a catheter to a patient. Thedevice broadly includes a platform, a flexible and at least partlypermeable strip, a release liner, and an attachment layer. The platformis configured to couple to the catheter. The strip presents first andsecond opposite surfaces. The strip is configured to be removablyattached to the patient along the first surface. The platform and stripare formed of different materials. The strip includes a skin-contactingadhesive layer adhered to the first surface. The release liner removablyattaches to the first surface so that the first surface is at leastpartly covered by the release liner before the strip is attached to thepatient. The attachment layer is located between and adheres theplatform and strip along the second surface. The attachment layercomprises a hot-melt adhesive material.

Other aspects and advantages of the present invention will be apparentfrom the following detailed description of the preferred embodiments andthe accompanying drawing figures.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

Preferred embodiments of the invention are described in detail belowwith reference to the attached drawing figures, wherein:

FIG. 1 is a perspective view of an intravenous catheter anchoring devicewith an adhesively interconnected anchoring component and a permeableadhesive strip constructed in accordance with a preferred embodiment ofthe present invention and showing the anchoring device attached to apatient's arm such that the anchoring device secures a single-lumencatheter with a suture hub to provide a peripherally inserted centralcatheter;

FIG. 2 is a perspective view of the intravenous catheter anchoringdevice of FIG. 1, showing the anchoring device with the secured catheterand a release liner attached to the permeable adhesive strip;

FIG. 3 is an exploded perspective view of the intravenous catheteranchoring device of FIGS. 1 and 2;

FIG. 4 is a cross-sectional elevational view of the intravenous catheteranchoring device of FIGS. 1-3;

FIG. 5 is an enlarged partial cross-sectional elevational view of theintravenous catheter anchoring device of FIGS. 1-4;

FIG. 6 is a perspective view of a second embodiment of the intravenouscatheter anchoring device showing a tubing collector that is adhered tothe patient with a permeable adhesive strip; and

FIG. 7 is a cross-sectional elevational view of the intravenous catheteranchoring device of FIG. 6.

The drawing figures do not limit the present invention to the specificembodiments disclosed and described herein. The drawings are notnecessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

An intravenous catheter anchoring assembly 10 for use in securing acatheter 12 to a patient is illustrated in FIG. 1. The catheteranchoring assembly 10 is combined with the catheter 12 to form anintravenous infusion assembly 14. In the usual manner, the infusionassembly 14 is connected to an intravenous administration set (notshown) and enables convenient and repetitive porting to the patient'sinternal venous system for intravenous therapy and generally forintroducing or removing fluids. More specifically, the illustratedcatheter anchoring assembly 10 functions as an intravenous sitesecurement device for removably attaching the catheter 12 to thepatient's arm A to prevent localized catheter movement, especially anyaxial catheter movement, i.e., “pistoning”.

As will be shown, another catheter anchoring embodiment disclosed hereinfunctions primarily as a tubing collector which secures the catheter'stubing. Tubing collectors generally permit removable attachment of thetubing of a catheter, an intravenous extension set, or of an intravenousadministration set to the patient and principally serve to store anexcess length of that tubing. Some tubing collectors permit limitedaxial tubing movement through the collector.

The illustrated embodiment of FIG. 1 specifically shows the infusionassembly 14 with the catheter 12 secured to the patient's arm A as aPICC. However, the catheter 12 may be used for subcutaneous access otherthan peripheral blood stream access without departing from the scope ofthe present invention. That is, the illustrated catheter anchoringassembly 10 provides an external mechanism for stabilizing thecatheter's position in various locations on the patient. For example,the catheter anchoring assembly 10 can be used to secure a catheter on apatient's chest (not shown) as a CVC. The catheter anchoring assembly 10broadly includes a patient-contacting strip 16, a platform 18, aretaining strap 20 removably attached to the platform 18, an interveningadhesive layer 22 (see FIG. 3) between the strip 16 and the platform 18,and release liners 24 (see FIG. 2) removably attached to the strip 16.

Turning to FIGS. 1-3, the catheter 12 permits fluids to be introducedand removed from the patient's venous system. The catheter 12 includestubing 26 having an internal bore that is also referred to as a lumen(see FIG. 2). The catheter 12 further includes proximal and distalsections 28, 30 (with “proximal” and “distal” referring to the relativeproximity to the intravenous administration set). As shown in FIG. 1,the distal section 30 extends into and out of the patient's body at apuncture location 32 (sometimes referred to as a venipuncture site). Thedistal section 30 also terminates (proximally) at a suture hub 34. Theproximal section 28 terminates (distally) at the suture hub 34 and at anend (not shown). The proximal and distal sections 28, 30 of the PICCcatheter 12 each include the single lumen, making the illustratedcatheter 12 a single lumen catheter. The lumen is configured in theusual manner to carry fluids to and from the patient. Those ordinarilyskilled in the art will appreciate, however, that the use of multiplelumen catheters are entirely within the ambit of the present invention.

As shown particularly in FIG. 3, the suture hub 34 is generallytraditional in design and includes a body 36 and oppositely extendingwing-shaped projections 38. The projections 38 each include a hole 40for securing the suture hub 34 with a suture. The body 36 iscylindrically shaped and includes tapered strain relief sections 42 thatrestrict some bending of the tubing 26 adjacent to the projections 38.The body 36 further includes an annular groove 44 (sometimes referred toas a suture groove). While the above described catheter 12 includesfeatures that are important with respect to some aspects of the presentinvention, it is entirely consistent with the principles of the presentinvention to use other types of catheters and catheter anchoringassemblies not depicted in the disclosed embodiments of the infusionassembly 14. Moreover, the present invention is ideally suited forsecuring a broad range of catheter shapes and sizes, as well asextension sets and administration sets. Some of these alternativecatheters and anchoring devices are disclosed in copending applicationfor U.S. patent Ser. No. 11/306,289, filed Dec. 21, 2005, entitledINTRAVENOUS CATHETER ANCHORING DEVICE, which is hereby incorporated byreference herein.

Referring to FIGS. 1-3, the illustrated platform 18 is unitary andincludes a base 46 and connectors 48. The base 46 is shaped like a flatplate and includes upper and lower surfaces 50, 52 and a contoured edge54 (see FIG. 3). The contoured edge 54 is formed with rounded corners 56and recessed scallops 58 between each of the corners 56. The upper andlower surfaces 50, 52 are substantially flat and give the base 46 auniform thickness.

Referring again to FIG. 3, the connectors 48 each include a post 60having a rounded end 62. Each connector 48 also includes a catch 64fixed to the corresponding post 60 and extending inwardly and upwardlyfrom the post 60. The catch 64 preferably is a thin plate including atop edge 66 and a side edge 68, and with a thickness that is smallerthan the thickness of the post 60. Preferably, the catches 64 extendfrom the post 60 in a generally inward direction (i.e., from the outermargin of the platform 18 toward the center of the platform 18). Morepreferably, the catches 64 extend so as to form pairs where the catches64 are coplanar. However, it is within the ambit of the presentinvention for the catch 64 to be variously positioned, sized, or includeother alternative surfaces for selective engagement with the hub 34 orwith other components of the catheter 12. Moreover, consistent with theprinciples of the present invention, the connectors 48 may bealternatively configured to include more than one catch 64 or othercatheter-engaging surface.

As will be described in greater detail, the catches 64 provide surfacesthat cooperatively contain and restrict movement of the hub 34 relativeto the platform 18. In particular, the side edges 68 are configured tocooperatively trap the suture hub 34 by restricting movement of theprojections 38. The side edges 68 restrict movement by extending alongan upright direction from the base 46 to the retaining strap 20. In thismanner, each pair of adjacent side edges 68 presents an opening with alateral width that is substantially continuous from the base 46 to theretaining strap 20. Thus, inadvertent twisting or bending of the hub 34will not permit the projections 38 to slip out of position from betweentheir respective pair of side edges 68. Moreover, the illustratedcatches 64 are effective for universally securing virtually all knowncatheter configurations.

Each of the posts 60 is attached adjacent a respective corner 56 of thebase 46 and angles upwardly from the upper surface 50 and away from base46. A first pair of the connectors 48 extend parallel to each other in afirst lateral direction and are similarly angled relative to the base 46so that they cooperatively define a primary attachment side 70 of theplatform 18. A second pair of the connectors 48 also extend parallel toeach other and cooperatively form another primary attachment side 70.The second pair are also angled relative to the base 46 at an anglesimilar to the first pair, but extend in an opposite lateral directionfrom the first pair. Each of the connectors 48 are spaced apart so thatthe distance between any two adjacent connectors 48 is about the same(thus forming the corners of an imaginary square).

The connectors 48 and base 46 are preferably injection molded of arelatively hard clear plastic to create the unitary platform 18.Alternatively, the platform 18 can be molded to include a relativelyflexible elastomeric insert material (e.g., silicone). Elastomericmaterials generally have a lower modulus of elasticity than hard plasticmaterials and also provide surfaces with a higher coefficient offriction. Therefore, such a material can be incorporated into theplatform 18 so that the platform 18 has a surface that grips thecatheter 12. Specifically, the elastomeric structure grips the catheter12 by frictionally engaging and by flexibly conforming to the catheter12. Additional details of the preferred platform 18 are disclosed in theabove incorporated Application.

Turning again to FIGS. 1-3, the catheter anchoring assembly 10 includesthe retaining strap 20. The illustrated retaining strap 20 is unitaryand is generally elongated and flat. As will be discussed in greaterdetail, the retaining strap 20 is also preferably flexible andelastomeric (see FIG. 2) to permit frictional engagement with thecatheter 12 and to conform to the shape of the catheter 12.

Turning to FIG. 3, the retaining strap 20 includes a body 72. The body72 includes spaced apart opposite attachment ends 74, each formed by apair of outwardly extending pull-tabs 76, 78, and a centrally locatedstretch portion 80 between the ends 74. The body 72 presents upper andlower surfaces 82, 84. The pull-tabs 76 provide a grasping surface forthe retaining strap 20 and each provides an attachment locationpreferably in the form of a through-hole for receiving a respective oneof the connectors 48 as will be discussed. In the preferred embodiment,the pull-tabs 78 are adjustable and have an elongated shape to includethree attachment locations, each in the form of through-holes. Thepull-tabs 76, 78 enable grasping of the retaining strap 20 and furtherinclude grasping ribs for that purpose.

The retaining strap 20 includes a substantially homogeneous material.More preferably, the retaining strap 20 is molded out of a substantiallyclear elastomeric silicon material. Also, the retaining strap 20 ispreferably molded in an injection molding process. However, it couldalso be formed by other molding processes, such as thermoforming, knownto those of ordinary skill in the art. Additional details of thepreferred retaining strap 20 are disclosed in the incorporatedApplication.

Turning to FIGS. 2-4, the retaining strap 20 is initially attached tothe platform 18 by preferably receiving two connectors 48 on one of theplatform's sides 64 within respective pull-tabs 70. The rounded end 62of post 60 is larger in diameter than the hole. Therefore, the elasticpull-tab 76 stretches outwardly so as to pass over end 62 and then bereceived on the post 60. The undersized hole and rounded end 62 furtherrestrict the pull-tab 76 from becoming unintentionally removed from theattached position. The top edge 66 restricts the pull-tab 76 fromlowering to a position adjacent the base 46. In other words, principallyalong the space between the posts 60, the catches 64 position theattached pull-tabs 76 into a position spaced from the base 46, althoughsuch spacing is not necessary and the catches 64 could be alternativelyconfigured to securely hold the catheter 12 but permit the strap 20 tobe closer to the platform 18.

In the illustrated embodiment, the retaining strap 20 is fully securedto the platform 18 by lowering the pull-tabs 78 (causing the body 72 toflex as shown in phantom in FIG. 2) so that the remaining two connectors48 can be received within two of the holes. The upwardly and outwardlyangled posts 60 restrict the retaining strap 20 from moving out of theattached position, as the strap 22 would have to be stretched to agreater extent to do so. Furthermore, the top edge 66 restricts thepull-tabs 76, 78 from being lowered relative to the posts 60 once thepull-tabs 76, 78 are installed thereon. In other words, principallyalong the space between the posts 60, the catches 64 position theattached pull-tabs 76, 78 into a position spaced from the base 46. Thus,the catches 64 also retain the stretch portion 80 of the strap 20 in aposition spaced from the base 46. Again, the principles of the presentinvention are applicable where such spacing is not provided between thestrap 20 and base 46 (e.g., where the strap 20 is closely adjacent tothe base 46).

As will be discussed, the strap 20, the base 46, and the catches 64cooperatively contain and restrict movement of the hub 34 relative tothe platform 18. As discussed above, the side edges 68 restrict lateralmovement by extending along an upright direction from the base 46 to theretaining strap 20. The base 46 and strap 20 cooperatively restrictvertical movement of the hub 34. Furthermore, the base 46, strap 20, andeach pair of adjacent side edges 68 present a respective opening with alateral width between the side edges 68 and a vertical height betweenthe base 46 and strap 20. The illustrated base 46, strap 20, and catches64 are effective for universally securing virtually all known catheterconfigurations.

The elastomeric retaining strap 20 preferably includes a lower modulusof elasticity than the platform 18, making the retaining strap 20 lessrigid than the platform 18. Therefore, when the retaining strap 20 isattached between connectors 48 under tension, the retaining strap 20elongates while the platform 18 deflects negligibly. In this manner, theplatform substantially retains its shape when the body is elasticallystretched to receive the catheter 12.

The catheter anchoring assembly 10 secures the catheter 12 as shown inFIGS. 1-3. In FIGS. 1 and 2, the catheter 12 axis is substantiallyorthogonal to the longitudinal axis of the strip 16 and platform 18. Asdiscussed, the retaining strap 20 is partially attached to the platform18 with connectors 48 being received in holes of the tabs 76. In someinstances, an edge of the retaining strap 20 is received within theannular groove 44 to further restrict axial movement of the catheter 12.

The pull-tabs 78 are then secured to the remaining connectors 48 bystretching the retaining strap 20 over the suture hub 34. Again, therounded ends 62 secure the pull-tabs 76, 78 onto the posts 60 with thetop edge 66 retaining the pull-tabs 76, 78 in a position spaced from thebase 46 and adjacent the ends 62. The platform 18 and strap 22 arepreferably configured and dimensioned so that the strap 22 iselastically stretched when the catheter is secured between the platform18 and strap 22, whereby the catheter 12 is gripped and axiallyretained. The suture hub 34 is arranged between the platform 18 andretaining strap 20 with the tubing 26 across the primary attachmentsides 70 and extending through oppositely spaced openings (see FIG. 2)cooperatively formed by the platform 18 and retaining strap 20. Asdiscussed above, a pair of catches 64 along with the base 46 andretaining strap 20 cooperatively form each of the respective openings.Furthermore, projections 38 are received respectively in the remainingoppositely spaced openings. Thus, the side edges 68 are configured toengage and restrict movement of the hub 34 relative to the platform 18.In this manner, the side edges 68, strap 20, and base 46 prevent the hub34 from twisting or bending that would permit inadvertent removal of thehub 34 from within the platform 18.

Again, the fully attached retaining strap 20 is preferably elasticallyelongated and under tension to force the catheter 12 against theplatform 18. Additional details of how the platform 18 and retainingstrap 20 operate to secure catheters in various orientations are furtherdisclosed in the above incorporated Application. While the abovedescribed platform 18 and strap 20 include features that are importantwith respect to some aspects of the present invention, it is entirelyconsistent with the principles of the present invention to use othertypes of catheter anchoring components not depicted in the embodimentsdisclosed herein. Moreover, the present invention is ideally suited forattaching other types of catheter anchoring components.

Turning back to FIGS. 1-4, the patient-contacting strip 16 is anadhesive-backed membrane that includes a substrate 86. The substrate 86is cut to have an elongated shape and includes ends 88 and recessedsides 90 extending longitudinally between the ends 88. The ends 88 eachinclude two extended portions 92 and recessed scallops 94 between thepair of extended portions 92. The shape of the illustrated strip 16 isintended for ornamental purposes and is the subject of co-pending U.S.Design Patent Application Serial No. 29/253,412, filed Feb. 6, 2006, andentitled ADHESIVE PATIENT-CONTACT STRIP FOR INTRAVENOUS CATHETERANCHORING DEVICES, which is hereby incorporated by reference herein. Thesubstrate 86 is preferably formed of a flexible and permeable material,although partial permeability of the substrate is contemplated by thepresent invention. More preferably, the substrate 86 is formed of afabric material. Furthermore, the substrate 86 preferably has athickness T of about 0.005 to 0.015 inches. More preferably, thesubstrate thickness is about 0.008 inches. The very small thickness ofthe illustrated substrate 86 enhances the flexibility of the strip 16 sothat the patient can comfortably wear the anchoring assembly 10 over aperiod of days or weeks.

The preferred substrate 86 also includes a surface energy of at leastabout 18 Dynes/cm or greater. More preferably, the substrate 86 includesa surface energy of about 43 Dynes/cm. A substrate's surface energyrefers to the molecular force of attraction between the substrate and anadhesive (i.e., a high surface energy equates with a high attractionforce). Most preferably, the substrate 86 includes polyester filamentsthat form interstices in the substrate 86 for receiving adhesive as willbe discussed further below. Furthermore, the most preferred material isa non-woven tricot fabric. However, the principles of the presentinvention are equally applicable to the strip 16 including other wovenor non-woven fabrics that are flexible and are thereby suitable for useas a patient-contacting strip.

The strip 16 further includes a skin-contacting adhesive layer 96 (seeFIGS. 1 and 5) coated over a lower side 98 of the substrate 86. Theadhesive layer 96 is preferably a pressure-sensitive adhesive (“PSA”)including an acrylic resin material and is suitable for adhering itselfto the substrate 86 as well as being removably adherent to human skin.More preferably, the adhesive layer 96 is provided with the substrate 86as a pre-assembled adhesive-backed membrane. The substrate 86 andadhesive layer 96 cooperatively permit the strip 16 to be flexible andthereby suitable for removable attachment to the skin of the patient.One preferred Tricot fabric and a preferred adhesive layer areincorporated into an adhesive-backed membrane sold under the designation“BIOFLEX®” by Scapa North America, 111 Great Pond Drive, Windsor, Conn.06095. However, the principles of the present invention are applicableto the use of other adhesives for removably adhering the substrate toskin.

Turning to FIGS. 2 and 3, the release liners 24 are preferably made ofkraft paper and include two sections 100 that are folded onto each otherto form a fold end 102 (see FIG. 3). Each of the release liners 24 isattached to the adhesive layer 96 along one of the respective sections100 so that the fold ends 102 are adjacent and the release liners 24slightly overlap. The release liners 24 preferably completely cover theadhesive layer 96. The unattached sections 100 provide convenientpull-tabs for removal of the respective release liners 24. In thismanner, the adhesive layer 96 may be exposed in a relatively sterilemanner just prior to adhering the strip 16 to the patient's skin.

Turning to FIGS. 3-5, the intermediate adhesive layer 22 is applied toan upper side 104 of the substrate 86. Preferably, the adhesive layer 22is a hot-melt adhesive which generally does not include solvent. Thus,the hot-melt adhesive can be repetitively softened by heat andsolidified by cooling. One exemplary hot-melt adhesive is designated asBostik HM 4229, which is a thermoplastic dimer-acid polyamide, and ismanufactured by Bostik Findley, Inc., 211 Boston Road, Middleton, Mass.01949. This adhesive has thermosel viscosity values as follows: at 160°C. the value is 27,800, at 180° C. the value is 11,600, at 200° C. thevalue is 5,975, at 225° C. the value is 2850, and at 250° C. the valueis 1525. Furthermore, the Bostik adhesive has a Shore A Hardness valueof 75 and a B&R Softening Point of 138° C. The Bostik adhesive istypically applied at ranges of about 180-204° C.

The adhesive layer 22 is preferably adherent to a low surface energysubstrate material, such as the material of the preferred substrate 86above. An adhesive that is applied to a low surface energy substratewill not “flow” (i.e., wet-out or spread out) along the substrate asreadily as an adhesive that is applied to a high surface energysubstrate. In addition, the composition of the adhesive and the ambientconditions also affect the adhesive's flowability. Preferably, theadhesive layer 22 is adherent to a substrate material with a surfaceenergy of at least about 18 Dynes/cm or greater.

The adhesive layer 22, when set, is a highly flexible but solid materialthat is die-cut to closely follow the shape of the platform 18 in orderto maximize the bonded surface area between the platform 18 and thesubstrate 86. However, it is consistent with the principles of thepresent invention that the adhesive layer 22 could be applied in a formmore similar to a liquid and could be applied by pouring or sprayingmethods known to those of ordinary skill in the art. Moreover, thepreferred adhesive material forming layer 22 has highly cohesivequalities for adhering different materials to one another, which in thepreferred embodiment includes the hard plastic forming the platform 18and the non-woven tricot fabric forming the strip 16.

Referring again to FIG. 2, the platform 18 is arranged so that the sides70 are spaced adjacent to respective recessed sides 90 of the strip 16.The platform 18 is bonded to the substrate 86 of strip 16 with theadhesive layer 22. The preferred construction is perhaps more detailedlyillustrated in FIGS. 4 and 5. In particular, with regard to the firstpreferred embodiment, the adhesive layer 22 is bonded to the lowersurface 52 of the platform 18 and the upper side 104 of the substrate86. As mentioned previously, the substrate 86 includes filaments thatform interstices therein. The adhesive layer 22 becomes mechanicallyinterlocked with the strip 16 by solidifying within the interstices andsurrounding at least some of the filaments.

Turning to FIGS. 3-5, the preferred hot-melt adhesive layer 22 ispreferably flowable from the upper side 104 into the interstices to adepth greater than half the thickness T in order to become fullymechanically interlocked with the substrate 86 (e.g., where the adhesivelayer 22 is “wedged” between and at least slightly under adjacent fibersof the substrate 86, as is best shown in FIG. 5). In the illustratedembodiment, a portion of the adhesive layer 22 remains spaced above theupper side 104 (see FIGS. 4 and 5). However, the principles of thepresent invention are applicable where the adhesive layer 22 is entirelyabsorbed within the substrate 86 and contacts the adhesive layer 96.

More preferably, the adhesive layer 22 flows from the upper side 104into close proximity with the lower side 98 so as to optimize themechanical interengagement with the substrate 86. Most preferably, theadhesive layer 22 does not penetrate through the adhesive layer 96 so asto contact the release liners 24. Thus, while the adhesive layer 22preferably remains spaced from and does not contact the adhesive layer96, the principles of the present invention are applicable where theadhesive layer 22 in fact contacts at least part of the adjacent side ofadhesive layer 96. Thus, the composition of the layers 22, 96 preventsthe closely adjacent layers 22, 96 from mixing with each other or thelayer 22 from penetrating the layer 96. The spacing and composition ofthe layers 22, 96 also prevents the adhesive layer 22 from becomingdisposed onto the release liners 24, which may adversely change theotherwise temporary bond between the adhesive layer 96 and releaseliners 24. The principles of the present invention are also applicableto other configurations of the adhesive layer 22 or strip 16 so that theadhesive layer 22 is restricted from permeating completely through thestrip's thickness or otherwise penetrating through the adhesive layer96. For example, the strip 16 could include an impermeable sectionspaced between adhesive layers 22, 96 to prevent flow of the adhesivelayer 22 up to adhesive layer 96.

Turning again to FIGS. 1-4, the adhesive layer 22 and strip 16 areconfigured so that the anchoring assembly 10 is comfortable for apatient. Particularly, the use of a very thin strip 16 and the highlyflexible adhesive layer 22, as discussed above, enables the strip 16 tobe more comfortably worn by the patient. While the illustrated strip 16has a thickness that would normally allow adhesive to permeatecompletely through the strip 16 and adversely affect bonding of thestrip 16 to the release liner 24, the characteristics of the adhesivelayer 22 and the strip 16 permit the adhesive layer 22 to be applied andsolidified without permeating completely through the adhesive layer 96.Moreover, it has been determined that the use of hot melt adhesiveprovides the desired adhesion between the platform 18 and strip 16 whilepermitting the strip 16 to be coated with Teflon®. Such coating ensuresthat the strip 16 retains a pristine condition and does not absorb bloodduring use.

The combined platform 18 and strip 16 are removably attachable to thepatient's skin as discussed above. The strip 16 and adhesive layer 22flex to conform to curved surfaces in the attachment site. Furthermore,the contoured shape of the relatively rigid platform 18 permits theplatform 18 to remain bonded to the strip 16 while being closelyarranged to the patient's skin even if it includes significantcurvature.

FIGS. 6-7 illustrate an alternative embodiment of the present invention.For purposes of brevity, primarily the differences of the alternativeembodiment from the first embodiment will be described.

Turning to FIG. 6, an alternative intravenous catheter anchoringassembly 200 includes an alternative platform 202 adhesively attached toa strip 204 by an intervening adhesive layer 206. The illustratedplatform 202 is a tubing collector including a body 208 presenting upperand lower surfaces 210, 212 (see FIG. 7). The body 208 further includesends 214 with arcuate troughs 216 spaced between the ends and separatedby ridges 218. The troughs 216 receive tubing (not shown).

Turning to FIG. 7, the strip 204 includes a fabric substrate 220 and askin-contacting adhesive layer 222 made of a pressure sensitiveadhesive. The illustrated adhesive layer 206 is located between theplatform 202 and strip 204 and also is flowable substantially throughthe substrate 220 in order to become fully mechanically interlocked withthe substrate 220. Thus, the preferred adhesive layer 206 is flowableinto the interstices so as to be closely adjacent the skin-contactingadhesive layer 222 without penetrating the adhesive layer 222. In thismanner, the adhesive layer 206 is restricted from attaching to therelease liner (not shown).

The preferred forms of the invention described above are to be used asillustration only, and should not be utilized in a limiting sense ininterpreting the scope of the present invention. Obvious modificationsto the exemplary embodiments, as hereinabove set forth, could be readilymade by those skilled in the art without departing from the spirit ofthe present invention.

The inventors hereby state their intent to rely on the Doctrine ofEquivalents to determine and assess the reasonably fair scope of thepresent invention as pertains to any apparatus not materially departingfrom but outside the literal scope of the invention as set forth in thefollowing claims.

1. An intravenous catheter anchoring device for securing a catheter to apatient, said device comprising: a platform being configured to coupleto the catheter; a flexible and at least partly permeable stripincluding a plurality of interstices therein and presenting first andsecond opposite surfaces, said strip configured to be removably attachedto the patient along the first surface, said strip including askin-contacting adhesive layer adhered to the first surface; a releaseliner removably attached to the first surface so that the first surfaceis at least partly covered by the release liner before the strip isattached to the patient; and an attachment layer located between andadhering the platform and strip along a wetted portion of the secondsurface, said attachment layer comprising an adhesive material that isflowable prior to being solidified, said attachment layer extending fromthe wetted portion into at least some of the interstices so that theadhesive material becomes solidified therein, said attachment layerbeing entirely spaced from the release liner when solidified so that theattachment layer is restricted from adhering the strip to the releaseliner.
 2. The device as claimed in claim 1, said adhesive materialcomprising a hot-melt adhesive.
 3. The device as claimed in claim 2,said hot-melt adhesive comprising thermoplastic polyamide.
 4. The deviceas claimed in claim 2, said strip having a surface energy of at leastabout 18 Dynes/cm.
 5. The device as claimed in claim 4, said striphaving a surface energy of about 43 Dynes/cm.
 6. The device as claimedin claim 5, said strip including a polyester substrate.
 7. The device asclaimed in claim 1, said adhesive material remaining flexible afterbeing solidified so that the strip is operable to conform to thepatient.
 8. The device as claimed in claim 1, said strip including anon-woven tricot fabric substrate.
 9. The device as claimed in claim 8,said substrate including filaments that form the intersticestherebetween, said attachment layer mechanically interlocking with atleast some of the filaments.
 10. The device as claimed in claim 9, saidadhesive material extending a depth greater than about half thethickness of the strip.
 11. The device as claimed in claim 1, saidattachment layer being spaced entirely from the skin-contacting adhesivelayer.
 12. The device as claimed in claim 1, said strip being permeablefrom the first surface to the second surface along the wetted portion ofthe second surface.
 13. The device as claimed in claim 12, said striphaving a thickness from the first surface to the second surface of about0.005 to 0.015 inches.
 14. The device as claimed in claim 13, said striphaving a thickness from the first surface to the second surface of about0.008 inches.
 15. An intravenous catheter anchoring device for securinga catheter to a patient, said device comprising: a platform beingconfigured to couple to the catheter; a flexible and at least partlypermeable strip presenting first and second opposite surfaces, saidstrip configured to be removably attached to the patient along the firstsurface, said platform and said strip being formed of differentmaterials, said strip including a skin-contacting adhesive layer adheredto the first surface; a release liner removably attached to the firstsurface so that the first surface is at least partly covered by therelease liner before the strip is attached to the patient; and anattachment layer located between and adhering the platform and stripalong the second surface, said attachment layer comprising a hot-meltadhesive material.
 16. The device as claimed in claim 15, said platformcomprising a first plastic material, said strip comprising a secondplastic material.
 17. The device as claimed in claim 16, said firstplastic material being selected from the group consisting of ABS, highdensity polyethylene, and polycarbonate. said second plastic materialcomprising polyester.
 18. The device as claimed in claim 15, saidhot-melt adhesive comprising thermoplastic polyamide.
 19. The device asclaimed in claim 15, said strip having a surface energy of at leastabout 18 Dynes/cm.
 20. The device as claimed in claim 19, said striphaving a surface energy of about 43 Dynes/cm.
 21. The device as claimedin claim 20, said strip including a polyester substrate.
 22. The deviceas claimed in claim 15, said adhesive material remaining flexible afterbeing solidified so that the strip is operable to conform to thepatient.
 23. The device as claimed in claim 15, said strip including anon-woven tricot fabric substrate.
 24. The device as claimed in claim23, said substrate including filaments, said attachment layermechanically interlocking with at least some of the filaments.
 25. Thedevice as claimed in claim 24, said adhesive material extending into thesubstrate a depth greater than about half the thickness of the strip.26. The device as claimed in claim 15, said attachment layer beingentirely spaced from the release liner when solidified so that theattachment layer is restricted from adhering the strip to the releaseliner.
 27. The device as claimed in claim 26, said attachment layerbeing spaced entirely from the skin-contacting adhesive layer.
 28. Thedevice as claimed in claim 15, said attachment layer located between andadhering the platform and strip along a wetted portion of the secondsurface, said strip being permeable from the first surface to the secondsurface along the wetted portion of the second surface.
 29. The deviceas claimed in claim 28, said strip having a thickness from the firstsurface to the second surface of about 0.005 to 0.015 inches.
 30. Thedevice as claimed in claim 29, said strip having a thickness from thefirst surface to the second surface of about 0.008 inches.